Through our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic
absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently
as possible to maximize our customers' profits. For more information about our services,
contact one of our experts today.
Note: this service is for Research Use Only and Not intended for clinical use.
Container closure integrity (CCI) is the ability of a container closure system (CCS) to maintain the sterility and product quality of sterile final pharmaceutical, biological, and vaccine products throughout their shelf-life.1 The container closure integrity testing (CCIT) is a thorough analysis of the container closure system to assess whether it has sterile barrier protection against potential contaminants, including microorganisms, reactive gases, and other substances. CCIT is a key step in understanding the biosafety and suitability of containers, and both the US Pharmacopoeia and the FDA impose stringent requirements on CCIT.
The current regulatory guidelines on how to assess the limits of CCI are different between countries and regions, and there is no gold standard for CCIT methods, so CCIT must take into account the intended use (conventional manufacturing or quality control) and product design ( Primary packaging, product dosage form)2. Alfa Chemistry's experts are committed to providing you with the most comprehensive testing method, providing a test solution that meets your expectations, and providing advanced equipment to test pharmaceutical CCS to meet the regulatory guidelines and ensure the safety of the product container closure system.
Alfa Chemistry's capabilities include but not limited to:
Deterministic Methods
Electrical Conductivity and Capacitance Test (HVLD) Laser-based Gas Headspace Analysis Mass Extraction Tracer Gas (Vacuum Mode) Vacuum Decay
Probabilistic Methods
Microbial Challenge by Immersion Tracer Liquid Tests Bubble Tests Tracer Gas (Sniffer Mode)
USP <1207.1> Package Integrity and Test Method Selection USP <1207.2> Package Integrity Leak Test Technologies USP <1207.3> Package Seal Quality Test Methods
FDA 21CFR211.94 Drug Product Containers and Closures
ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological / Biological Products
Alfa Chemistry has a wide range of equipment, such as:
UV Spectrometer
Infrared Spectrometer
NMR Spectrometer
Gas Chromatography
Gas Chromatography Mass Spectrometer
High Performance Liquid Chromatography
Liquid Chromatography Mass Spectrometer
Gel Permeation Chromatography
Fluorescence Spectrometer
Diffraction Spectrometer
Thermogravimetric Analysis
Differential Scanning Calorimeter
Alfa Chemistry's advantages:
Short Detection Cycle
Competitive Price
Experienced Team of Experts
First-class Equipment
Reliable Results
Familiarity with Various Standards
References
Ewan S. (2015) 'White Paper: Container Closure Integrity Control versus Integrity Testing during Routine Manufacturing.' PDA J Pharm Sci Technol. 69(3):461-5.
Brown H. (2017) 'Container Closure Integrity Testing-Practical Aspects and Approaches in the Pharmaceutical Industry.' PDA J Pharm Sci Technol. 71(2):147-162.